NCT06457308

Brief Summary

Osteoporosis weakens bones with age, increasing fracture risk. Exercise improves physical function and reduces falls, crucial for preventing osteoporotic fractures, especially with balance, resistance, and multi-component training. Agility exercise, integrating various aspects like aerobic, strength, balance, and cognitive tasks, is promising for fall prevention in older adults, though its effectiveness in osteoporosis is not extensively studied. This study compares agility and resistance exercise impacts on physical function and balance stability in postmenopausal osteoporosis. Fifty-one women (average age: 68±6.3y, BMI: 22.3±2.7 kg/m2) were divided into agility exercise (AG), resistance exercise (RG), and control groups (CG) through purposive sampling. AG and RG received added intervention training once a week for 2 hours over 12 weeks. Main outcomes included physical function and balance stability measured through various tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

April 6, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

postmenopausal osteoporosisagility exercisephysical functionmulti-component exercisefall prevention

Outcome Measures

Primary Outcomes (7)

  • Physical function of upper limb strength

    arm curl in 30 secs

    after the completed training course, about 12 weeks

  • Physical function of upper limbs strength

    Hand grip

    after the completed training course, about 12 weeks

  • Physical function of lower limbs

    Walking speed

    after the completed training course, about 12 weeks

  • Physical function of dynamic balance

    Up and go test

    after the completed training course, about 12 weeks

  • Physical function of lower limbs

    Sit to stand in 30 secs

    after the completed training course, about 12 weeks

  • Physical function of static balance

    One leg stand test

    after the completed training course, about 12 weeks

  • Stability index

    Biodex balance system device

    after the completed training course, about 12 weeks

Study Arms (3)

Agility exercise training.

EXPERIMENTAL

Participants attend training class focused on agility training. Rope ladders and cones are used to perform multiple tasks of direction changes, acceleration and deceleration of footsteps, hand and foot coordination and spatial orientation training.

Biological: Physical training of agility

Resistance exercise training.

ACTIVE COMPARATOR

Participants attend training class focused on resistance training. Resistance training for upper and lower limb muscles and core muscles, including squats, use of elastic bands, and simple bars.

Biological: Physical training of resistance

Control

NO INTERVENTION

Participants only receive osteoporosis education usual care.

Interventions

A grouped training for older adults in the community. The training classed lasted for 12 weeks, one session a week for 120 mins, and are under instructed by a trained experienced sport instructor. Use rope ladders and cones to perform multiple tasks of direction changes, acceleration and deceleration of footsteps, hand and foot coordination and spatial orientation training,

Agility exercise training.

A grouped training for older adults in the community. The training classed lasted for 12 weeks, one session a week for 120 mins, and are under instructed by a trained experienced sport instructor. Resistance training for upper and lower limb muscles and core muscles, including squats, use of elastic bands, and simple bars

Resistance exercise training.

Eligibility Criteria

Age50 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostmenopausal osteoporosis
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with osteoporosis( diagnosed with DXA, T-score≦-2.5 in L-spine or hip)
  • postmenopausal, more than 50 years old,

You may not qualify if:

  • unable to attend the training sessions due to physical problems
  • had joined previous exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chen, Ying-Chen

Tainan, Taiwan

Location

Related Publications (4)

  • Donath L, van Dieen J, Faude O. Exercise-Based Fall Prevention in the Elderly: What About Agility? Sports Med. 2016 Feb;46(2):143-9. doi: 10.1007/s40279-015-0389-5.

    PMID: 26395115BACKGROUND
  • Lichtenstein E, Morat M, Roth R, Donath L, Faude O. Agility-based exercise training compared to traditional strength and balance training in older adults: a pilot randomized trial. PeerJ. 2020 Apr 14;8:e8781. doi: 10.7717/peerj.8781. eCollection 2020.

    PMID: 32328344BACKGROUND
  • Morat M, Morat T, Zijlstra W, Donath L. Effects of multimodal agility-like exercise training compared to inactive controls and alternative training on physical performance in older adults: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2021 Feb 25;18(1):4. doi: 10.1186/s11556-021-00256-y.

    PMID: 33632117BACKGROUND
  • Miko I, Szerb I, Szerb A, Bender T, Poor G. Effect of a balance-training programme on postural balance, aerobic capacity and frequency of falls in women with osteoporosis: A randomized controlled trial. J Rehabil Med. 2018 Jun 15;50(6):542-547. doi: 10.2340/16501977-2349.

    PMID: 29767227BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Non-randomized, quasi-experimental design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2024

First Posted

June 13, 2024

Study Start

July 14, 2021

Primary Completion

May 31, 2022

Study Completion

December 31, 2022

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations